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Editorial 1: The uncharted territory of

Context • Several space events planned well in advance have proceeded amidst the COVID- 19 pandemic without much attention. • on 16th July 2020, UAE launched its first Mars Orbiter Mission Hope • On July 23 launched its surface rover mission Tianwen-1. • On July 30, USA launched 's Mars 2020 Perseverance rover mission • In addition to these ,the first trip to on a commercial enterprise built by Space X, the completion of the Chinese ‘BeiDou’ navigation system, and the U.S. statement that conducted a “non- destructive test of a space-based anti-satellite weapon” all portray a trend that outer space is witnessing a welter of new activity.

Growth of • The price tag for reaching low Earth orbit has declined by a factor of 20 in a decade. • NASA’s cost about $54,500 per kg; now, SpaceX’s Falcon 9 advertises a cost of $2,720 per kg. • In a decade, the cost could be less than $100 per kg. • It enhances human space travel possibilities by leveraging new commercial capabilities. • According to a Bank of America Report, the $350 billion space market today will touch $2.7 trillion by 2050. • Space industries are likely to follow a path akin to the software industry. • When Apple allowed developers to design apps for the iPhone, it unleashed innovations that put more technology in the hands of common people and transformed lives. • Starlink, the constellation being constructed by SpaceX to provide global Internet access, plans more than 10,000 mass-produced small in low Earth orbit. • It hopes to transcend the digital divide and provide everyone, everywhere access to services such as distance education and telemedicine. • Amazon’s Project Kuiper received U.S. Federal Communications Commission approvals for more than 3,000 micro-satellites. • In a decade, 80,000 such satellites could be in space compared to less than 3,000 at present. • Companies such as Planet, Spire Global and Iceye are using orbital vantage points to collect and analyse data to deliver fresh insights in weather forecasting, global logistics, crop harvesting and disaster response. • Space could prove attractive for high-tech manufacturing too. • In short, an exciting new platform is opening up for entrepreneurs.

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Challenges in Fulfilling Potential • No Multilateral Framework o Outer space has become democratised, commercialised and crowded. o The Outer Space of 1967 enshrines the idea that space should be “the province of all mankind” and “not subject to national appropriation by claims of sovereignty”. o The , Space Liability Convention, and the Space expanded provisions of the . o These multilateral frameworks for governance of outer space are becoming obsolescent. o The Treaty of 1979 was not ratified by major space-faring nations. o does not have a dispute settlement mechanism o It is silent on collisions and debris and offers insufficient guidance on interference with others’ space assets. o These gaps heighten the potential for conflict in an era of congested and breakneck technological change.

• Non-State Entities o The legal framework for use of outer space is state-centric o It places responsibility on states alone. o However, non-state entities are now in the fray for commercial and utilisation. o Some states are providing frameworks for resource recovery through private enterprises based on the notion that this is not expressly forbidden for non-state actors. o U.S. President Donald Trump’s Executive Order of April 20202 on Encouraging International Support for the Recovery and Use of Space Resources falls in this category. o According to NASA, the asteroid named 16 Psyche is so rich in heavy metals that it is worth $10,000 quadrillion. o The incentive to proceed is evident. o On the other hand, some scholars and governments view this as violation of the existing space law in the spirit if not the letter. o The lack of alignment of domestic and international frameworks risks a damaging free-for-all competition for celestial resources involving actors outside the space framework. • Military Space Systems o Space is the highest ground.

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o States are investing in military space systems for communications, navigation, and reconnaissance purposes, so as to ensure operability of a range of capabilities. o Reliance of militaries on satellite systems means that space assets become potential targets. o So investment in technologies that can disrupt or destroy space-based capabilities is under way. o The space arms race is difficult to curb, especially since almost all space technologies have military applications. o For example, satellite constellations are commercial, but governments could acquire their data to monitor military movements. o Despite concerns about military activity in outer space for long, not much progress has been made in addressing them. o The UN General Assembly passed a resolution on Prevention of an Arms Race in Outer Space since 1982. o Chinese- and Russian-backed Treaty proposals were initiated in 2008 and updated in 2014. o Groups of Governmental Experts have not helped in making progress. o The EU’s International Code of Conduct for Outer Space Activities has not gained traction. o For various legal, technical, and political reasons these efforts have not advanced at the Conference on Disarmament o The current geopolitical situation does not hold hope for addressing concerns of a space arms race.

India and Need for Speedy Legislation • has invested enormous resources in its space programme through the ISRO. • More importantly, our space assets are crucial for India’s development. • Our future plans are ambitious. These include Mission Chandrayan: a landing on the Moon, Mission Aditya: the first Indian solar observatory, Mission Gaganyan: the first crewed orbital mission and installation of a modular space station in 2030. • This calendar is designed to establish India as a space superpower by the end of the decade. • The proposed involvement of private players and the creation of an autonomous body IN-SPACe (Indian National Space Promotion and Authorisation Centre) under the for permitting and regulating activities of the private sector are welcome efforts.

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• However, the space environment that India faces requires us to go beyond meeting technical milestones. • We need a space legislation enabling coherence across technical, legal, commercial, diplomatic and defence goals. Conclusion • Our space vision needs to address global governance, regulatory and issues. • As space opens up our space vision needs broadening too.

References • https://www.thehindu.com/opinion/op-ed/the-uncharted-territory-of-outer- space/article32449729.ece • https://economictimes.indiatimes.com/news/science/china-launches-mars- probe-in-space-race-with-us/articleshow/77122263.cms?from=mdr • https://mars.nasa.gov/news/8724/nasa-ula-launch-mars-2020-perseverance- rover-mission-to-red-planet/ • https://www.financialexpress.com/lifestyle/science/isros-space-station-and- human-mission-programme-us-companies-keen-on-space-collaboration-with- india/1863246/

Editorial 2: The participants we need in Phase 3 trials

Context • Two COVID-19 vaccines have been accepted for Phase 3 trials after passing the Phase 1 trial for safety and the Phase 2 trial for both safety and the vaccine’s ability to induce a virus-neutralizing antibody with or without T-cell-mediated immunity. • Vaccine-induced immunity has not yet been proven to protect against COVID-19, but the likelihood of protection is quite high. • While everyone else can avoid exposure to COVID-19, healthcare workers have to work in high-risk environments with repeated exposure to infection. • Vulnerable groups such as the elderly and those with co-morbidities have five- fold to 15-fold greater mortality when they get COVID-19 than others. • Therefore, healthcare workers and vulnerable groups need to be treated as priority categories for vaccination when the COVID-19 vaccine is available.

Details • Process of development of vaccine proceeds through three phases of clinical trials.

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• First Phase: Small groups of people receive the trial vaccine. • Second Phase: trial vaccine is given to people who have characteristics (such as age and physical health) similar to those for whom the new vaccine is intended. • Third Phase: trial Vaccine is tested on several thousand people to reassure its efficacy and safety. During this phase, participants either receive the vaccine or a placebo. • Placebo is anything which looks like real treatment but it is actually not. • Efficacy of the vaccine is determined by comparing the prevalence of infection in the group that was administered the vaccine with the one which received a placebo. • T Cell-mediated immunity is an immune response that does not involve antibodies. • T cell-mediated immunity is the activation of phagocytes, antigen- specific cytotoxic T-lymphocytes, and the release of various cytokines in response to an antigen. • Natural infection induces both a virus-neutralizing antibody and T-cell-mediated immunity. • Reports of reinfection by the novel coronavirus in previously infected individuals are extremely rare • It suggests that natural infection is indeed protective in the vast majority. • When a vaccine candidate produces similar immune responses, the probability of it being protective against the disease is high. • A vaccine that has passed Phase 2 should therefore be assumed to be protective, unless proved otherwise in a Phase 3 trial. • It will provide additional evidence of freedom from rare side-effects. Once cleared in Phase 3, the vaccine is registered by the drug regulatory agency and vaccination of the general public carried out as per national policy.

Objective of Vaccination • In the short term, Vaccine protects vulnerable individuals from serious disease and death. • One more short-term goal of Vaccine is to protect occupationally exposed individuals from acquiring and unknowingly transmitting infection to their patients and family. • In long term, Vaccine aims to eradicate the viral infection.

Measure of Effectiveness • Effectiveness of a vaccine is not measured by number of infection and death prevented by vaccine

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• Concentration of antibodies created by a vaccine in a single individual can be a measure of its strength but not effectiveness. • Antibodies are only surrogate markers of protection. • To demonstrate that the vaccine achieves the short-term objectives, it is important that the vaccine trials include a good proportion of special groups of individuals. • The twin clinical outcomes of reduced mortality in vaccinated vulnerable individuals and reduced infection rates among healthcare workers will quickly provide unequivocal clinical measures of vaccine efficacy.

Who Should be Included in Phase 3 Trials? • Under normal circumstances, Phase 3 vaccination trials include only healthy adult volunteers. • Once the vaccine is found to be safe and effective, small bridging studies are conducted among vulnerable subjects. • However, in the pandemic situation, if vulnerable groups are deliberately included from the beginning in Phase 3 trials, we can proceed straightaway to immunizing these vulnerable groups once trials are completed. • Vulnerable people and healthcare workers should get preferentially opportunity to register themselves as volunteers. • information on vaccine efficacy and safety from these subgroups will be of paramount importance • It will facilitate prioritized vaccination of those who did not have an opportunity to enroll as volunteers for the trial and those who got placebo injection.

Health Care Workers • Historically, healthcare workers have often been the first to volunteer to participate in several physiological and pharmacological studies of an experimental nature. • Participation of healthcare workers will motivate and enthuse members of the general public to participate in the trial and make recruitment easier. • The loss of many colleagues, mandatory quarantine of increasing numbers of infected healthcare workers, the struggle to cope with the escalating number of cases in the face of workforce depletion, and the worries about risk to their immediate family have eroded the morale of all healthcare workers in India. • Inclusion of healthcare workers in the Phase 3 vaccine trial may prove to be the silver lining and boost the sagging morale of healthcare workers. • Duke Research Institute started HERO (Healthcare Worker Exposure Response and Outcomes) encourages healthcare workers to participate in all COVID-19 clinical trials including vaccine trials.

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• The Indian Medical Association and nursing and paramedical professional organizations have enrolled all members of the healthcare work force. • They should come together on a platform similar to HERO and encourage healthcare workers to enrol for the Phase 3 COVID-19 vaccination trials. • If the vaccine is efficacious, at least half the trial participants will be protected (the other half will be in the placebo arm). • Those healthcare workers who have already contracted COVID-19 and who do not need the vaccine should be listed in the National Registry. • Of those who have so far not been infected, IgG antibody testing will identify antibody positive subjects who do not need vaccination. • Sero-prevalence of IgG antibody in healthcare workers is likely to be 30-40% as is the case currently in our metros. • Only the remaining proportion of healthcare workers will still be susceptible. • It should be possible to accommodate remaining healthcare workers into the Phase 3 trial protocol without much difficulty.

Conclusion

• Professional organizations, civil society, regulatory agency, the Indian Council of Medical Research and vaccine manufacturers should act immediately and allow and encourage enrolment of healthcare workers and vulnerable people in Phase 3 trials.

References

• https://www.thehindu.com/opinion/lead/the-participants-we-need-in-phase-3- trials/article32459266.ece